Systems, devices, and methods for integrated patient service center

ABSTRACT

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

BACKGROUND

A blood sample for use in laboratory testing is often obtained by way ofvenipuncture, which typically involves inserting a hypodermic needleinto a vein on the subject. Blood extracted by the hypodermic needle maybe drawn directly into a syringe or into one or more sealed vials forsubsequent processing. When a venipuncture may be difficult orimpractical such as on a newborn infant, a non-venous puncture such as aheel stick or other alternate site puncture may be used to extract ablood sample for testing. After the blood sample is collected, theextracted sample is typically packaged and transferred to a processingcenter for analysis.

Unfortunately, conventional sample collection and testing techniques ofbodily fluid samples has drawbacks. One of them is the lack of easilyaccessible sampling sites and patient service centers in locations thatare more readily accessible to the patient.

SUMMARY

At least some of disadvantages associated with the prior art areovercome by at least some or all of the embodiments described in thisdisclosure. Although the embodiments herein are typically described inthe context of obtaining a blood sample, it should be understood thatthe embodiments herein are not limited to blood samples and can also beadapted to acquire other fluid(s) or bodily sample(s) for analysis.

In one embodiment, an integrated patient service center is providedcomprising: a user accommodation section adapted to locate a user in atleast one position that enables an interaction between the station andthe user; a user interface adapted to permit a user to input datarelevant to the user; wherein said at least one position enables theuser to position a portion of their body onto a work surface forobtaining patient service; a secured, temperature controlled samplestorage location that is configured to be accessible through a firstopening; and a lockable cover for securing the a user interface but notthe sample storage location.

In another embodiment, an integrated patient service center is providedcomprising a user accommodation section adapted to locate a user in atleast one position that enables an interaction between the station andthe user; a user interface adapted to permit a user to input datarelevant to the user; wherein said at least one position enables theuser to position a portion of their body onto a work surface forobtaining patient service; a secured, temperature controlled samplestorage location that is configured to be accessible through a firstopening and a second opening, wherein a key, code, or structure to openone opening does not open the other opening.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-8 show views of integrated patient service center according toembodiments as described herein.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It may be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a compound” may includemultiple compounds, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for a samplecollection well, this means that the sample collection well may or maynot be present, and, thus, the description includes both structureswherein a device possesses the sample collection well and structureswherein sample collection well is not present.

By way of non-limiting example, one embodiment of an integrated patientservice center herein provides a location for a practitioner to sit andobtain a bodily fluid or other sample from the patient. A work surfacesuch as a table is provided so that a patient has a surface on whichthey can position the target site on the subject to allow for sampling.The work surface can have one or more thermal controlled sites whereinthe temperature of the target site on the patient may be brought to adesired temperature. By way of example and not limitation, oneembodiment may heat a finger or other target site to improve blood flowand thus blood yield from a fingerstick. In one embodiment, thetemperature is sufficient to increase blood flow to yield 120 uL ofsample. In one embodiment, the temperature is sufficient to increaseblood flow to yield 130 uL of sample. In one embodiment, the temperatureis sufficient to increase blood flow to yield 140 uL of sample. In oneembodiment, the temperature is sufficient to increase blood flow toyield 150 uL of sample. Optionally, the thermal controlled site is ashaped surface is contoured to match that of the target site on apatient.

Optionally, the integrated patient service center has an integratedtable with a heater in it for finger warming as areplacement/alternative for/to our finger warmers. In one embodiment,that table can have the biohazard bin built in and is at optimal heightfor facilitating the flow of gravity in the finger as droplets form. Itis designed for a technician and patient to be sitting together. Thetable may optionally go into a treatment with an integrated passthroughwindow specially designed to transfer urine into the blood collectionarea and into devices.

In one non-limiting example, the integrated patient service center maybe an indoor unit. The integrated patient service center may bepermanent, but mobile. The integrated patient service center may beconfigure so that one person at the unit, providing service to anotherperson. The integrated patient service center may be 30×48×52″approximately, err on the side of taller and skinnier.

The integrated patient service center may have security features. Theintegrated patient service center may be a lockable whole unit. Theintegrated patient service center may be have a lockable individualdrawer unit for after-hours access. The integrated patient servicecenter may be have a lock for electronics in the unit.

The integrated patient service center may be secured during movement.The integrated patient service center may be moveable but stable whenlocked. The integrated patient service center may have wheels, andmaneuverable, but can lock stably into place once in position. Theintegrated patient service center may have a table that is sturdy, ableto be able to carry the weight of 2 people's arms resting on it.

The integrated patient service center may have electrical power to it.The integrated patient service center may have a power strip hiddeninternally, only have single protruding cable—rest of cables out ofsight. The integrated patient service center may have 5-7 electronicdevices to be connected, all in main unit (not on side table). Theintegrated patient service center may have 15-20 Amp out.

The integrated patient service center may be configured to be versatile.The integrated patient service center may have table/workspaces thatfold out at least one off the side of the unit and one in the front. Theintegrated patient service center may have possibly adjustable heightsfor tables.

The integrated patient service center may be easily cleanable. Theintegrated patient service center may be easily cleanable surfaceespecially the side table. The integrated patient service center mayhave FDA/food handling quality for the side table. The integratedpatient service center may configured to stay looking clean with use.The integrated patient service center may be configure have a screen orcreate some space and provide some privacy.

In one embodiment, the integrated patient service center may beconfigured for 2 people sitting on standard chairs. The integratedpatient service center may be have some small quantity of cleaningsupplies for the station: surface wipes, hand sanitizer etc. Theintegrated patient service center may have areas for holding some smallquantity of office supplies. The integrated patient service center mayhave a 3 gallon bin—215×150×450 mm, 2 lb. The integrated patient servicecenter may have a small trash bin 7-13 gallons approx. The integratedpatient service center may have a small storage area. The integratedpatient service center may have a small storage area for personalitems—lockable.

Usage Scenarios:

Case 1: there would already be a counter/check-in place before peopleare directed to the integrated patient service center.

Case 2: The integrated patient service center would be located withinthe larger retail area and directly come up to it.

In one embodiment, there will be a privacy screen (separate, aboutperson height) that will be drawn around the integrated patient servicecenter during the procedure, and removed the rest of the time.

Optionally, if parts of the integrated patient service center can pop upabove the screen height, that would allow for branding visibility evenwhen the screen is drawn.

Optionally, in all cases the integrated patient service center will bepushed up with the back against the wall, i.e. when the technician issitting facing the integrated patient service center, they will befacing the wall.

Optionally, the technician may not necessarily be sitting facing theintegrated patient service center the whole day though.

Optionally, the back of the integrated patient service center should befairly flat, and this would affect the overall shape.

Optionally, possibility of changing, since store layouts might changeover time.

Optionally, some cases the integrated patient service center might be ina corner.

Optionally, side table, ideally adjustable height with just a littlerange, maybe a few inches. Chairs that the people will sit on areprobably adjustable too. Optionally, ideally can translate and rotate.

Optionally, if the table could come towards you, and one could rotateabout the corner, for maximum customizability. The white wireframe‘table’ in the mock up is too big right now but a customer needs to fitbetween the potential back wall and the table, no matter how big orsmall the customer, and to be able to get in and out easily.

Optionally, the table is mountable on either sides of the integratedpatient service center, so that the procedure could take place on eitherside. Possibly having two tables, one on each side. Optionally, oneshould still be able to reach across to access a drawer on the otherside of the integrated patient service center while at the side table(the footprint constraint already takes care of that, judging from theuser tests). Optionally, one could have separate support leg(s) as longas things can be folded away/compact when not in use.

As seen in FIGS. 1 to 8, some common items in the integrated patientservice center include but are not limited to printer, touchscreenmonitor or non-touch monitor, keyboard tray, keyboard, mouse, USB WifiDongle, Power Strip/Surge Protector, Scanner, Collection Table(s),Refrigerator, Refrigerator Thermometer, Supply Cabinet/Drawer(s), WifiHotspot.

One embodiment may have a table that fold out to sides and middle,24-28″ high, imagine children's school desk, may be value in havingadjustable height, needs to bear weight. Optionally, the patient servicecenter has sharps container, biohazard bin, lancets, BCD, alcohol swabs,gauze, bandaid, pens, gloves, mask, stamp (PROCESSED) or other officesupply.

Referring now to FIG. 1, this embodiment shows an integrated patientservice center 10 that has a lockable screen or structure 12 that movesfrom a first position to a second position to close the opening 20 thatallows access to the monitor, scanner, and other electronics. Thecontrolled temperature storage unit 30 is provided that is lockable forstorage of fluid samples obtained from the patient.

FIG. 2 shows that lockable screen or structure 12 is movable to coveropening 20. A sharps container or trash receptacle 40 is shown in FIG.2.

FIG. 3 is a transparent view showing the various component inside anintegrated patient service center. It should be understood that thestorage unit 30 that is temperature controlled is not covered by thestructure 12 when the structure is closed. This allows for the samplesin the storage unit 30 to be accessed without have to give access to allof the unit. Optionally, some embodiment may have a second door on theside to allow for access into the storage unit 30. Optionally, someembodiment may have a second door on the back of the center 10 to allowfor access into the storage unit 30.

FIG. 4 shows yet another embodiment, wherein table or work surface 50 ismovable.

FIGS. 5 and 6 show various views of an integrated patient service centersimilar to those previously described herein.

As seen in FIG. 7, the top down plan view shows that the shape of theservice center 10 can be configured preferentially direct one portion100 away from publically viewable areas to provide some more privacy asto information being shown on the any computer monitor. It can also bepositioned to enable a user to see information in the service center 10and be facing somewhat towards the patient who will be near the worksurface 50. It also provides for a larger surface 110 to provide forsignage or other display information.

While the teachings has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, the table may have thermal control areas to increase bloodflow to the target area and thus increase the speed with whichsufficient blood or other bodily fluid can be drawn from the subject.The heating is used to bring the target tissue to about 40 C to 50 C.Optionally, the heat brings target tissue to a temperature range ofabout 44 to 47 C.

Additionally, concentrations, amounts, and other numerical data may bepresented herein in a range format. It is to be understood that suchrange format is used merely for convenience and brevity and should beinterpreted flexibly to include not only the numerical values explicitlyrecited as the limits of the range, but also to include all theindividual numerical values or sub-ranges encompassed within that rangeas if each numerical value and sub-range is explicitly recited. Forexample, a size range of about 1 nm to about 200 nm should beinterpreted to include not only the explicitly recited limits of about 1nm and about 200 nm, but also to include individual sizes such as 2 nm,3 nm, 4 nm, and sub-ranges such as 10 nm to 50 nm, 20 nm to 100 nm, etc. . . .

The publications discussed or cited herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.All publications mentioned herein are incorporated herein by referenceto disclose and describe the structures and/or methods in connectionwith which the publications are cited. The following applications arefully incorporated herein by reference for all purposes: in U.S.Provisional Patent Application No. 61/435,250, filed Jan. 21, 2011(“SYSTEMS AND METHODS FOR SAMPLE USE MAXIMIZATION”), and U.S. PatentPublication No. 2009/0088336 (“MODULAR POINT-OF-CARE DEVICES, SYSTEMS,AND USES THEREOF”). The following applications are fully incorporatedherein by reference for all purposes: U.S. Pat. No. 8,088,593; U.S. Pat.No. 8,380,541; U.S. patent application Ser. No. 13/769,798, filed Feb.18, 2013; U.S. patent application Ser. No. 13/769,779, filed Feb. 18,2013; U.S. Pat. App. Ser. No. 61/766,113 filed Feb. 18, 2013, U.S.patent application Ser. No. 13/244,947 filed Sep. 26, 2011;PCT/US2012/57155, filed Sep. 25, 2012; U.S. application Ser. No.13/244,946, filed Sep. 26, 2011; U.S. patent application Ser. No.13/244,949, filed Sep. 26, 2011; and U.S. Application Ser. No.61/673,245, filed Sep. 26, 2011, U.S. Patent Application Ser. No.61/786,351 filed Mar. 15, 2013, U.S. Patent Application Ser. No.61/697,797 filed Sep. 6, 2012, U.S. Patent Application Ser. No.61/852,484 filed Mar. 15, 2013, and U.S. Patent Application Ser. No.61/733,886 filed Dec. 5, 2012, the disclosures of which patents andpatent applications are all hereby incorporated by reference in theirentireties for all purposes.

While the above is a complete description of the preferred embodiment asdescribed herein, it is possible to use various alternatives,modifications and equivalents. Therefore, the scope of the presentinvention should be determined not with reference to the abovedescription but should, instead, be determined with reference to theappended claims, along with their full scope of equivalents. Anyfeature, whether preferred or not, may be combined with any otherfeature, whether preferred or not. The appended claims are not to beinterpreted as including means-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase“means for.” It should be understood that as used in the descriptionherein and throughout the claims that follow, the meaning of “a,” “an,”and “the” includes plural reference unless the context clearly dictatesotherwise. Also, as used in the description herein and throughout theclaims that follow, the meaning of “in” includes “in” and “on” unlessthe context clearly dictates otherwise. Finally, as used in thedescription herein and throughout the claims that follow, the meaningsof “and” and “or” include both the conjunctive and disjunctive and maybe used interchangeably unless the context expressly dictates otherwise.Thus, in contexts where the terms “and” or “or” are used, usage of suchconjunctions do not exclude an “and/or” meaning unless the contextexpressly dictates otherwise.

This document contains material subject to copyright protection. Thecopyright owner (Applicant herein) has no objection to facsimilereproduction of the patent documents and disclosures, as they appear inthe US Patent and Trademark Office patent file or records, but otherwisereserves all copyright rights whatsoever. The following notice shallapply: Copyright 2013 Theranos, Inc.

What is claimed is:
 1. An integrated patient service center unit for usewith a user and a user interface, the unit comprising: a station havinga lockable cover securing at least one portion of the station; a useraccommodation section defined by the station and adapted to enable aninteraction between the station and the user; a user interface holderadapted to support a user interface to permit the user to input data,wherein the lockable cover is configured for securing the user interfaceand the user interface holder; a refrigerated, temperature controlledsample storage location that is configured to be accessible through afirst opening; and a separate lockable access panel for the samplestorage location, separate from the lockable cover.
 2. The integratedpatient service center of claim 1 further comprising a plurality oflockable wheels coupled to the station.
 3. The integrated patientservice center of claim 1 further comprising a table coupled to thestation.
 4. The integrated patient service center of claim 3 wherein thetable is configured fold out from at least one off a side surface of thestation.
 5. The integrated patient service center of claim 3 wherein thetable is configured fold out from at least a front surface of thestation.
 6. The integrated patient service center of claim 3 wherein thetable has an adjustable height.
 7. The integrated patient service centerof claim 3 where the table comprises separate support leg(s) as long asthings can be folded away/compact when not in use.
 8. The integratedpatient service center of claim 1 further comprising a privacy screenadapted to be drawn around the integrated patient service center tocreate a privacy space when rendering patient service.
 9. The integratedpatient service center of claim 8 wherein at least one portion ofintegrated patient service center is configured to extend above a heightof the privacy screen, that would allow for branding visibility evenwhen the privacy screen is drawn.
 10. The integrated patient servicecenter of claim 1 comprising at least one of the following: a printer, atouchscreen monitor, a non-touch monitor, a keyboard tray, a keyboard, acomputer mouse, a USB Wifi Dongle, a Power Strip, a Surge Protector, aScanner, a Collection Table, a Refrigerator, a Refrigerator Thermometer,a Supply Cabinet, a supply Drawer, or a Wifi Hotspot device.
 11. Theintegrated patient service center of claim 1 the patient service centerhas a sharps container and a biohazard bin.
 12. The integrated patientservice center of claim 1 lockable cover is movable from a firstposition to a second position to close an opening that allows access tothe user interface.
 13. The integrated patient service center of claim 1further comprising a controlled temperature storage unit that islockable for storage of fluid samples obtained from the patient.
 14. Theintegrated patient service center of claim 1 wherein the separatelockable access panel is on a side of the station to access the samplestorage location.
 15. The integrated patient service center of claim 1wherein the separate lockable access panel is on a rear surface of thestation to allow access to the sample storage location.
 16. Theintegrated patient service center of claim 3 wherein the table comprisesa thermal control areas to increase blood flow to a target area and thusincrease the speed with which sufficient blood or other bodily fluid canbe drawn from a subject.
 17. The integrated patient service center ofclaim 16 the thermal control areas are configured to heat a targettissue to about 40° C. to 50° C.
 18. The integrated patient servicecenter of claim 16 the thermal control areas are configured to heat atemperature range of about 44° C. to 47° C.
 19. An integrated patientservice center comprising: a station having a lockable cover securing atleast one portion of the station; a user accommodation section of thestation adapted to locate a user in at least one position that enablesan interaction between the station and the user; a user interfaceadapted to permit a user to input data relevant to the user; whereinsaid at least one position enables the user to position a portion oftheir body onto a work surface for obtaining patient service; and asecured, temperature controlled sample storage location that isconfigured to be accessible through a first opening and a secondopening, wherein a key, code, or structure to open one opening does notopen another opening.